Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number (022)
Federal Register: September 8, 2009 (Volume 74, Number 172)
Notices
Page 46203-46214
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DOCID:fr08se09-79
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2004-N-0451
(formerly Docket No. 2004N-0226)
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 022
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
Page 46204
SUMMARY: The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 022'' (Recognition List Number: 022), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
DATES: Submit written or electronic comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document.
ADDRESSES: Submit written requests for single copies of ``Modifications to the List of Recognized Standards, Recognition List Number: 022'' to the Division of Small Manufacturers, International and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave, Bldg. 66, rm. 4613, Silver
Spring, MD 20993-0002. Send two self-addressed adhesive labels to assist that office in processing your requests, or fax your request to 301-847-8149. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see FOR FURTHER INFORMATION CONTACT). Submit electronic comments by e-mail: standards@cdrh.fda.gov. This document may also be accessed on FDA's Internet site at http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including
Recognition List Number: 022 modifications and other standards related information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 3632, Silver Spring, MD 20993-0002, 301- 796-6574.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 of the act allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards.
Modifications to the initial list of recognized standards, as published in the Federal Register, are identified in table 1 of this document.
Table 1.--Federal Register Citation
February 25, 1998 (63 FR 9561)
May 27, 2005 (70 FR 30756)
October 16, 1998 (63 FR 55617)
November 8, 2005 (70 FR 67713)
July 12, 1999 (64 FR 37546)
March 31, 2006 (71 FR 16313)
November 15, 2000 (65 FR 69022)
June 23, 2006 (71 FR 36121)
May 7, 2001 (66 FR 23032)
November 3, 2006 (71 FR 64718)
January 14, 2002 (67 FR 1774)
May 21, 2007 (72 FR 28500)
October 2, 2002 (67 FR 61893)
September 12, 2007 (72 FR 52142)
April 28, 2003 (68 FR 22391)
December 19, 2007 (72 FR 71924)
March 8, 2004 (69 FR 10712)
September 9, 2008 (73 FR 52358)
June 18, 2004 (69 FR 34176)
March, 18, 2009 (74 FR 11586)
October 4, 2004 (69 FR 59240)
...................................
These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains ``hypertext markup language (HTML)'' and ``portable document format (PDF)'' versions of the list of ``FDA Recognized Consensus Standards.'' Both versions are publicly accessible at the agency's Internet site. See section VI of this document for electronic access information.
Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 022
FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices.
FDA will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the agency's searchable database. FDA will use the term ``Recognition List Number: 022'' to identify these current modifications.
In table 2 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.
In section III of this document, FDA lists modifications the agency is making that involve the initial addition of standards not previously recognized by FDA.
Table 2.
Replacement
Old Recognition No.
Recognition No.
Standard
Change
-
Anesthesia
1-37
1-80
CGA C-9:2004 (Reaffirmed 2008) Standard
Withdrawn and replaced
Color Marking of Compressed Gas
with newer version
Containers for Medical Use
Page 46205
1-68
1-81
CGA V-5:2008 Diameter-Index Safety System Withdrawn and replaced
Noninterchangeable Low Pressure
with newer version
Connections for Medical Gas Applications
1-51
..................... ASTM F1100-90 (1997) Standard
Withdrawn
Specification for Ventilators Intended for Use in Critical Care
1-59
..................... ASTM F1456-01 Standard Specification for
Withdrawn
Minimum Performance and Safety
Requirements for Capnometers
-
Biocompatibility
2-64
..................... ANSI/AAMI/ISO 10993-5:1999 Biological
Contact person, Extent
Evaluation of Medical Devices--Part 5:
of recognition and
Tests for In Vitro Cytotoxicity
Relevant guidance
2-82
..................... ASTM F2147-01 Standard Practice for Guinea Contact person and
Pig: Split Adjuvant and Closed Patch
Extent of recognition
Testing for Contact Allergens
2-83
2-136
ASTM E1262-88 (Reapproved 2008) Standard
Withdrawn and replaced
Guide for Performance of Chinese Hamster with newer version
Ovary Cell/Hypoxanthine Guanine
Phosphoribosyl Transferase Gene Mutation
Assay
2-84
2-137
ASTM E1263-97 (Reapproved 2008) Standard
Withdrawn and replaced
Guide for Conduct of Micronucleus Assays with newer version in Mammalian Bone Marrow Erythrocytes
2-85
2-138
ASTM E1280-97 (Reapproved 2008) Standard
Withdrawn and replaced
Guide for Performing the Mouse Lymphoma
with newer version
Assay for Mammalian Cell Mutagenicity
2-87
..................... ISO 10993-10:2002 Biological Evaluation of Extent of recognition
Medical Devices--Part 10: Tests for
and Relevant guidance
Irritation and Delayed-type
Hypersensitivity
2-90
2-139
ASTM E1397-91 (Reapproved 2008) Standard
Withdrawn and replaced
Practice for In Vitro Rat Hepatocyte DNA with newer version
Repair Assay
2-91
2-140
ASTM E1398-91 (Reapproved 2008) Standard
Withdrawn and replaced
Practice for In Vivo Rat Hepatocyte DNA
with newer version
Repair Assay
2-93
..................... ASTM F763-04 Standard Practice for Short- Extent of recognition
Term Screening of Implant Materials
and Contact person
2-94
..................... ASTM F981-04 Standard Practice for
Extent of recognition
Assessment of Compatibility of
and Contact person
Biomaterials for Surgical Implants with
Respect to Effect of Materials on Muscle and Bone
2-95
2-141
ASTM F1984-99 (Reapproved 2008) Standard
Withdrawn and replaced
Practice for Testing for Whole Complement with newer version
Activation in Serum by Solid Materials
2-97
2-142
ASTM F1983-99 (Reapproved 2008) Standard
Withdrawn and replaced
Practice for Assessment of Compatibility with newer version of Absorbable/Resorbable Biomaterials for
Implant Applications
2-98
..................... ANSI/AAMI/ISO 10993-1:2003 Biological
Title, Extent of
Evaluation of Medical Devices--Part 1:
recognition, Relevant
Evaluation and Testing
guidance and Contact person
2-99
2-143
ASTM F1904-98 (Reapproved 2008) Standard
Withdrawn and replaced
Practice for Testing the Biological
with newer version
Responses to Particles in vivo
2-100
..................... ASTM E1372-95 (Reapproved 2003) Standard
Contact person
Test Method for Conducting a 90-Day Oral
Toxicity Study in Rats
2-106
2-144
ASTM F619-03 (Reapproved 2008) Standard
Withdrawn and replaced
Practice for Extraction of Medical
with newer version
Plastics
2-108
..................... ASTM F1905-98(2003) Standard Practice for Contact person and
Selecting Tests for Determining the
Extent of recognition
Propensity of Materials to Cause
Immunotoxicity
2-114
..................... ASTM F1877-05 Standard Practice for
Extent of recognition
Characterization of Particles
and Contact person
Page 46206
2-115
..................... ASTM F895-84 (Reapproved 2006) Standard
Extent of recognition,
Test Method for Agar Diffusion Cell
Relevant guidance and
Culture Screening for Cytotoxicity
Contact person
2-116
2-145
ASTM F1439-03 (Reapproved 2008) Standard
Withdrawn and replaced
Guide for Performance of Lifetime
with newer version
Bioassay for the Tumorigenic Potential of
Implant Materials
2-118
..................... ANSI/AAMI/ISO 10993-11:2006 Biological
Extent of recognition,
Evaluation of Medical Devices--Part 11:
Relevant guidance and
Tests for Systemic Toxicity
Contact person
2-119
..................... ASTM F813-07 Standard Practice for Direct Contact person
Contact Cell Culture Evaluation of
Materials for Medical Devices
2-121
2-146
ASTM F2148-071 Standard Practice for
Withdrawn and replaced
Evaluation of Delayed Contact
with newer version
Hypersensitivity Using the Murine Local
Lymph Node Assay (LLNA)
2-122
..................... ASTM F719-81 (Reapproved 2007)1 Standard
Contact person and
Practice for Testing Biomaterials in
Relevant guidance
Rabbits for Primary Skin Irritation
2-124
..................... ASTM F750-87 (Reapproved 2007)1 Standard
Extent of recognition,
Practice for Evaluating Material Extracts Relevant guidance and by Systemic Injection in the Mouse
Contact person
2-125
..................... ASTM F749-98 (Reapproved 2007)1 Standard
Extent of recognition,
Practice for Evaluating Material Extracts Relevant guidance and by Intracutaneous Injection in the Rabbit Contact person
2-126
..................... ASTM F748-06 Standard Practice for
Extent of recognition,
Selecting Generic Biological Test Methods Relevant guidance and for Materials and Devices
Contact person
2-128
2-147
USP 32-NF26 Biological Tests 2009
Withdrawn and replaced
Biological Reactivity Test, In Vitro--
with newer version
Direct Contact Test
2-129
2-148
USP 32-NF26 Biological Tests Withdrawn and replaced
Biological Reactivity Test, In Vitro--
with newer version
Elution Test
2-130
2-149
USP 32-NF26 Biological Tests Withdrawn and replaced
Biological Reactivity Tests, In Vivo
with newer version
Procedure--Preparation of Sample
2-131
2-150
USP 32-NF26 Biological Tests Withdrawn and replaced
Biological Reactivity Test, In Vivo,
with newer version
Classification of Plastics--
Intracutaneous Test
2-132
2-151
USP 32-NF26 Biological Tests Withdrawn and replaced
Biological Reactivity Tests, In Vivo,
with newer version
Classification of Plastics--Systemic
Injection Test
2-133
..................... ASTM F1408-97 (Reapproved 2008) Standard
Contact person
Practice for Subcutaneous Screening Test for Implant Materials
2-134
..................... ASTM F2065-00 (2006) Standard Practice for Contact person
Testing for Alternative Pathway
Complement Activation in Serum by Solid
Materials
2-135
..................... AAMI/ANSI/ISO 10993-12:2007 Biological
Extent of recognition,
Evaluation of Medical Devices--Part 12:
Relevant guidance and
Sample Preparation and Reference
Contact person
Materials
-
Dental/ENT
4-69
4-178
ISO 6872:2008 Dentistry--Ceramic Materials Withdrawn and replaced with newer version
4-73
4-179
ISO 7405: 2008 Dentistry--Evaluation of
Withdrawn and replaced
Biocompatibility of Medical Devices Used with newer version in Dentistry
4-175
..................... ANSI ASA S3.46-1997 (R 2007) Methods of
Reaffirmation
Measurement of Real-Ear Performance
Characteristics of Hearing Aids
-
General
Page 46207
5-12
5-47
ISO 10012:2003 Measurement Management
Withdrawn and replaced
Systems--Requirements for Measurement
with newer version
Processes and Measuring Equipment
5-15
5-48
ANSI/ASQ Z1.9-2008 Sampling Procedures and Withdrawn and replaced
Tables for Inspection by Variables for
with newer version
Percent Nonconforming
5-27
..................... IEC 60601-1-1 Ed. 2.0 2000 Medical
Title
Electrical Equipment--Part 1-1: General
Requirements for Safety--Collateral
Standard: Safety requirements for Medical
Electrical Systems
5-36
..................... ISO/TR 16142:2006 Medical Devices--
Title
Guidance on the Selection of Standards in
Support of Recognized Essential
Principles of Safety and Performance of
Medical Devices
5-41
..................... IEC 60601-1-4 (2000) Consol. Ed. 1.1
Title
Medical Electrical Equipment--Part 1-4:
General Requirements for Safety--
Collateral Standard: Programmable
Electrical Medical Systems
5-44
5-49
IEC 60601-1-8, Ed. 1 Medical Electrical
Withdrawn and re-
Equipment--Part 1-8: General Requirements recognized previous for Safety--Collateral Standard: Alarm
version
Systems--Requirements, Tests and
Guidelines--General Requirements and
Guidelines for Alarm Systems in Medical
Equipment
-
General Hospital/General Plastic Surgery
6-63
6-216
ISO 8536-7:2009 Infusion Equipment for
Withdrawn and replaced
Medical Use--Part 7: Caps Made of
with newer version
Aluminum-plastics Combinations for
Infusion Bottles
6-112
..................... ANSI/AAMI PB70:2003 Liquid Barrier
Contact person
Performance and Classification of
Protective Apparel and Drapes Intended for Use in Health Care Facilities
6-118
..................... ASTM F2196-02 Standard Specification for
CFR citation and
Circulating Liquid and Forced Air Patient product code
Temperature Management Devices
6-144
..................... ASTM D5712--051 Standard Test Method for
Title and Contact
Analysis of Aqueous Extractable Protein
person in Natural Rubber and Its Products Using the Modified Lowry Method
6-145
..................... ASTM D3578-051 Standard Specification for Title and Contact
Rubber Examination Gloves
person
6-147
..................... ASTM D6978-05 Standard Practice for
Contact person and
Assessment of Resistance of Medical
Relevant guidance
Gloves to Permeation by Chemotherapy
Drugs
6-149
..................... ASTM D7160-05 Standard Practice for
Contact person
Determination of Expiration Dating for
Medical Gloves
6-150
..................... ASTM D7161-05 Standard Practice for
Contact person
Determination of Real Time Expiration
Dating of Mature Medical Gloves Stored
Under Typical Warehouse Conditions
6-165
..................... ASTM D6977-041 Standard Specification for Title and Contact
Polychloroprene Examination Gloves for
person
Medical Application
6-167
..................... ASTM D6319-00a (Reapproved 2005)1 Standard Title and Contact
Specification for Nitrile Examination
person
Gloves for Medical Application
6-168
..................... ASTM D3577-091 Standard Specification for Withdrawn and replaced
Rubber Surgical Gloves
with newer version
6-175
..................... ASTM D5151-06 Standard Test Method for
Contact person
Detection of Holes in Medical Gloves
6-178
..................... ASTM D6124-06 Standard Test Method for
Contact person
Residual Powder on Medical Gloves
6-183
..................... ASTM D5250-061 Standard Specification for Title and Contact
Poly(vinyl chloride) Gloves for Medical
person
Application
6-186
6-217
ASTM F1670-08 Standard Test Method for
Withdrawn and replaced
Resistance of Materials Used in
with newer version
Protective Clothing to Penetration by
Synthetic Blood
Page 46208
6-205
6-218
USP 32:2009 Nonabsorbable Surgical Suture Withdrawn and replaced with newer version
6-206
6-219
USP 32:2009 Sterile Sodium Chloride
Withdrawn and replaced for Irrigation
with newer version
6-207
6-220
USP 32:2009 Absorbable Surgical Suture
Withdrawn and replaced with newer version
6-208
6-221
USP 32:2009 Tensile Strength
Withdrawn and replaced with newer version
6-209
6-222
USP 32:2009 Sutures--Diameter
Withdrawn and replaced with newer version
6-210
6-223
USP 32:2009 Sutures Needle Attachment Withdrawn and replaced with newer version
6-211
6-224
USP 32:2009 Sterile Water for
Withdrawn and replaced
Irrigation
with newer version
6-212
6-225
USP 32:2009 Heparin Lock Flush
Withdrawn and replaced
Solution
with newer version
6-213
6-226
USP 32:2009 Sodium Chloride Injection Withdrawn and replaced with newer version
-
In Vitro Diagnostics
7-156
7-195
CLSI M02-A10, Performance Standards for
Withdrawn and replaced
Antimicrobial Disk Susceptibility Tests
with newer version
7-158
7-196
CLSI M07-A8, Methods for Dilution
Withdrawn and replaced
Antimicrobial Susceptibility Tests for
with newer version
Bacteria that Grow Aerobically
7-160
7-197
CLSI M35-A2, Abbreviated Identification of Withdrawn and replaced
Bacteria and Yeast
with newer version
7-78
7-198
CLSI M23-A3, Development of In Vitro
Withdrawn and replaced
Susceptibility Testing Criteria and
with newer version
Quality Control Parameters
7-177
7-199
CLSI M100-S19 Performance Standards for
Withdrawn and replaced
Antimicrobial Susceptibility Testing
with newer version
7-161
7-200
CLSI M48-A, Laboratory Detection and
Withdrawn and replaced
Identification of Mycobacteria
with newer version
7-102
..................... NCCLS H1-A5, Tubes and Additives for
Contact Person
Venous Blood Specimen Collection
7-101
..................... NCCLS H51-A, Assays of vonWillebrand
Contact Person
Factor Antigen and Ristocetin Cofactor
Activity
7-165
..................... CLSI H20-A2, Reference Leukocyte (WBC)
Contact Person
Differential Count (Proportional) and
Evaluation of Instrumental Methods
7-103
7-201
CLSI H3-A6, Procedures for the Collection Withdrawn and replaced of Diagnostic Blood Specimens by
with newer version
Venipuncture
7-81
7-202
CLSI C28-A3 Defining, Establishing, and
Withdrawn and replaced
Verifying Reference Intervals in the
with newer version
Clinical Laboratory
7-144
7-203
CLSI H04-A6, Procedures and Devices for
Withdrawn and replaced the Collection of Diagnostic Capillary
with newer version
Blood Specimens
-
Materials
8-32
8-163
ASTM F1586-08 Standard Specification for
Withdrawn and replaced
Wrought Nitrogen Strengthened 21 Chromium- with newer version 10Nickel-3Manganese-2.5Molybdenum
Stainless Steel Bar for Surgical Implants
(UNS S31675)
Page 46209
8-44
8-164
ASTM F136-081 Standard Specification for
Withdrawn and replaced
Wrought Titanium-6 Aluminum-4 Vanadium
with newer version
ELI (Extra Low Interstitial) Alloy for
Surgical Implant Applications (UNS
R56401)
8-49
8-165
ASTM F1058-08 Standard Specification for
Withdrawn and replaced
Wrought 40Cobalt-20Chromium-16Iron-
with newer version 15Nickel-7Molybdenum Alloy Wire and Strip for Surgical Implant Applications (UNS
R30003 and UNS R30008)
8-50
8-166
ASTM F1091-08 Standard Specification for
Withdrawn and replaced
Wrought Cobalt-20 Chromium-15 Tungsten-10 with newer version
Nickel Alloy Surgical Fixation Wire (UNS
R30605)
8-52
8-167
ASTM F1350-08 Standard Specification for
Withdrawn and replaced
Wrought 18 Chromium-14 Nickel-2.5
with newer version
Molybdenum Stainless Steel Surgical
Fixation Wire (UNS S31673)
8-53
8-168
ASTM F1472-081 Standard Specification for Withdrawn and replaced
Wrought Titanium -6Aluminum -4Vanadium
with newer version
Alloy for Surgical Implant Applications
(UNS R56400)
8-76
8-169
ASTM F138-08 Standard Specification for
Withdrawn and replaced
Wrought 18 Chromium-14 Nickel-2.5
with newer version
Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
8-79
8-170
ASTM F961-08 Standard Specification for
Withdrawn and replaced 35Cobalt-35 Nickel-20 Chromium-10
with newer version
Molybdenum Alloy Forgings for Surgical
Implants (UNS R30035)
8-81
8-171
ASTM F1609-08 Standard Specification for
Withdrawn and replaced
Calcium Phosphate Coatings for
with newer version
Implantable Materials
8-86
8-172
ASTM F1926/F1926M-08 Standard Test Method Withdrawn and replaced for Evaluation of the Environmental
with newer version
Stability of Calcium Phosphate Granules,
Fabricated Forms, and Coatings
8-94
8-173
ASTM F601-03 (Reapproved 2008) Standard
Withdrawn and replaced
Practice for Fluorescent Penetrant
with newer version
Inspection of Metallic Surgical Implants
8-95
8-174
ASTM F629-02 (Reapproved 2007)1 Standard
Withdrawn and replaced
Practice for Radiography of Cast Metallic with newer version
Surgical Implants
8-110
8-175
ASTM F1377-08 Standard Specification for
Withdrawn and replaced
Cobalt-28 Chromium-6 Molybdenum Powder
with newer version for Coating of Orthopedic Implants (UNS
R30075)
8-118
8-176
ASTM F2503-08 Standard Practice for
Withdrawn and replaced
Marking Medical Devices and Other Items
with newer version for Safety in the Magnetic Resonance
Environment
8-133
8-177
ASTM F2129-08 Standard Test Method for
Withdrawn and replaced
Conducting Cyclic Potentiodynamic
with newer version
Polarization Measurements to Determine the Corrosion Susceptibility of Small
Implant Devices
8-143
8-178
ASTM F648-071 Standard Specification for
Withdrawn and replaced
Ultra-High-Molecular-Weight Polyethylene with newer version
Powder and Fabricated Form for Surgical
Implants
8-144
8-179
ASTM F754-08 Standard Specification for
Withdrawn and replaced
Implantable Polytetrafluoroethylene
with newer version
(PTFE) Sheet, Tube, and Rod Shapes
Fabricated from Granular Molding Powders
8-146
8-180
ASTM F2066-08 Standard Specification for
Withdrawn and replaced
Wrought Titanium-15 Molybdenum Alloy for with newer version
Surgical Implant Applications (UNS
R58150)
8-148
8-181
ASTM F899-09 Standard Specification for
Withdrawn and replaced
Wrought Stainless Steels for Surgical
with newer version
Instruments
8-152
8-182
ASTM F1537-08 Standard Specification for
Withdrawn and replaced
Wrought Cobalt-28-Chromium-6-Molybdenum
with newer version
Alloys for Surgical Implants (UNS R31537,
UNS R31538, and UNS R31539)
8-160
8-183
ASTM F560-08 Standard Specification for
Withdrawn and replaced
Unalloyed Tantalum for Surgical Implant
with newer version
Applications (UNS R05200, UNS R05400)
Page 46210
8-161
8-184
ASTM F2516-072 Standard Test Method for
Withdrawn and replaced
Tension Testing of Nickel-Titanium
with newer version
Superelastic Materials
8-162
8-185
ASTM F451-08 Standard Specification for
Withdrawn and replaced
Acrylic Bone Cement
with newer version
-
OB-GYN/Gastroenterology
9-34
..................... ISO 4074:2002/Cor.1:2003(E):, Natural
Relevant guidance
Latex Rubber Condoms--Requirements and
Test Methods, Technical Corrigendum 1
9-41
9-58
ASTM D6324-08 Standard Test Methods for
Withdrawn and replaced
Male Condoms Made from Polyurethane
with newer version
9-43
..................... ISO 16038:2005 Rubber condoms--Guidance on Relevant guidance the Use of ISO 4074 in the Quality
Management of Natural Rubber Latex
Condoms
9-56
..................... ASTM D3492-08 Standard Specification for
Relevant guidance
Rubber Contraceptives (Male Condoms)
9-57
..................... ISO 4074:2002/Cor.2:2008(E) Natural Latex Relevant guidance
Rubber Condoms--Requirements and Test
Methods, Technical Corrigendum 2
I. Orthopedics
11-172
11-211
ASTM F1798-97 (Reapproved 2008) Standard
Withdrawn and replaced
Guide for Evaluating the Static and
with newer version
Fatigue Properties of Interconnection
Mechanisms and Subassemblies Used in
Spinal Arthrodesis Implants
11-178
11-212
ASTM F1440-92 (Reapproved 2008) Standard
Withdrawn and replaced
Practice for Cyclic Fatigue Testing of
with newer version
Metallic Stemmed Hip Arthroplasty Femoral
Components Without Torsion
11-192
11-213
ASTM F1223-08 Standard Test Method for
Withdrawn and replaced
Determination of Total Knee Replacement
with newer version
Constraint
11-198
11-214
ASTM F0382-99 (Reapproved 2008) Standard
Withdrawn and replaced
Specification and Test Method for
with newer version
Metallic Bone Plates
11-204
11-215
ASTM F897-02 (Reapproved 2007) Standard
Withdrawn and replaced
Test Method for Measuring Fretting
with newer version
Corrosion of Osteosynthesis Plates and
Screws
11-205
11-216
ASTM F1264-03 (Reapproved 2007)1 Standard Withdrawn and replaced
Specification and Test Methods for
with newer version
Intramedullary Fixation Devices
11-209
11-217
ASTM F2083-081 Standard Specification for Withdrawn and replaced
Total Knee Prosthesis
with newer version
-
Radiology
12-17
12-192
NEMA MS 8-2008 Characterization of the
Withdrawn and replaced
Specific Absorption Rate for Magnetic
with new version
Resonance Imaging Systems
12-48
12-193
AIUM AOL 2008 Acoustic Output Labeling
Withdrawn and replaced
Standard for Diagnostic Ultrasound
with newer version
Equipment Revision 1- A Standard for How
Manufacturers Should Specify Acoustic
Output Data
12-58
12-194
ANSI/HPS N43.6-2007 Sealed Radioactive
Withdrawn and replaced
Sources--Classification
with newer version
12-69
12-195
NEMA MS 6-2008 Determination of Signal-to- Withdrawn and replaced
Noise Ratio and Image Uniformity for
with newer version
Single-Channel Non-Volume Coils in
Diagnostic MR Imaging
12-95
12-196
NEMA MS 2-2008 Determination of Two-
Withdrawn and replaced
Dimensional Geometric Distortion in
with newer version
Diagnostic Magnetic Resonance Images
12-100
..................... NEMA UD 3-2004 Standard for Real Time
Contact person
Display of Thermal and Mechanical
Acoustic Output Indices on Diagnostic
Ultrasound Equipment
Page 46211
12-105
..................... NEMA UD 2-2004 Acoustic Output Measurement Contact person
Standard for Diagnostic Ultrasound
Equipment Version 3
12-139
..................... AIUM AOMS-2004 Acoustic Output Measurement Title and Contact
Standard for Diagnostic Ultrasound
person
Equipment
12-140
..................... AIUM RTD1-2004 Standard for Real-Time
Title and Contact
Display of Thermal and Mechanical
person
Acoustic Output Indices on Diagnostic
Ultrasound Equipment Revision 1
12-146
..................... IEC 60601-2-17 (2004) Medical Electrical
Title
Equipment--Part 2-17: Particular
Requirements for the Safety of
Automatically-controlled Brachytherapy
Afterloading Equipment
12-147
..................... IEC 60601-2-5: (2000) Medical Electrical
Title
Equipment--Part 2-5: Particular
Requirements for the Safety of Ultrasonic
Physiotherapy Equipment Ed. 2.0
12-169
12-197
IEC 60601-2-22 (1995) Medical Electrical
Withdrawn and re-
Equipment--Part 2-22: Particular
recognized previous
Requirements for Basic Safety and
version
Essential Performance of Surgical,
Cosmetic, Therapeutic and Diagnostic
Laser Equipment--Edition 2.0
12-178
..................... IEC 60601-2-45 Ed. 2.0, (2001), Medical
Title electrical equipment--Part 2-45:
Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
12-182
12-198
IEC 60601-2-37 (2004), (2005) Amendment 2, Withdrawn and re-
Medical Electrical Equipment--Part 2-37: recognized previous
Particular Requirements for the Safety of version
Ultrasonic Medical Diagnostic and
Monitoring Equipment
12-185
12-199
IEC 60601-1-3: 1994 Medical Electrical
Withdrawn and re-
Equipment--Part 1: General Requirements
recognize previous for Safety 3. Collateral Standard:
version
General Requirements for Radiation
Protection in Diagnostic X-ray Equipment--
First Edition
12-186
12-200
IEC 60601-2-29 (1999) Medical Electrical
Withdrawn and re-
Equipment Part 2-29: Particular
recognized previous
Requirements for the Safety of
version
Radiotherapy Simulators--Second Edition
-
Software/Informatics
13-16
13-29
CLSI LIS01-A2 Specification for Low-Level Withdrawn and replaced
Protocol to Transfer Messages Between
with newer version
Clinical Laboratory Instruments and
Computer Systems
L. Sterility
14-55
..................... ANSI/AAMI/ISO 14160:1998/(R) 2008
Reaffirmation
Sterilization of Single-use Medical
Devices Incorporating Materials of Animal
Origin--Validation and Routine Control of
Sterilization by Liquid Chemical
Sterilants
14-88
..................... ANSI/AAMI/ ISO 14937:2000 Sterilization of Contact person
Health Care Products--General
Requirements for Characterization of a
Sterilizing Agent and the Development,
Validation, and Routine Control of a
Sterilization Process for Medical
Devices.
14-116
..................... ANSI/AAMI ST72:2002 Bacterial Endotoxins-- Relevant guidance and
Test Methodologies, Routine Monitoring,
Extent of recognition and Alternatives to Batch Testing
14-135
..................... ANSI/AAMI ST63:2002 Sterilization of
Relevant Guidance
Health Care Products--Requirements for the Development, Validation, and Routine
Control of an Industrial Sterilization
Process for Medical Devices--Dry Heat
14-164
..................... ANSI/AAMI ST81:2004 Sterilization of
Contact Person
Medical Devices--Information to be
Provided by the Manufacturer for the
Processing of Resterilizable Medical
Devices
14-195
..................... ANSI/AAMI/ISO 11140-1:2005 Sterilization
Relevant Guidance, of Health Care Products--Chemical
Extent of Recognition
Indicators--Part 1: General Requirements and Contact person
Page 46212
14-220
14-263
ANSI/AAMI ST79:2006/A1:2008 Comprehensive Withdrawn and replaced
Guide to Steam Sterilization and
with newer version
Sterility Assurance in Health Care
Facilities
14-223
..................... ANSI/AAMI/ISO 11138-1:2006 Sterilization
Relevant Guidance of Health Care Products--Biological
Indicators--Part 1: General Requirements
14-224
..................... ANSI/AAMI/ISO 11137-1:2006 Sterilization
Relevant Guidance of Health Care Products--Radiation--Part 1: Requirements for Development,
Validation, and Routine Control of a
Sterilization Process for Medical Devices
14-225
..................... ANSI/AAMI/ISO 11137-2:2006 Sterilization
Relevant Guidance of Health Care Products--Radiation--Part 2: Establishing the Sterilization Dose
14-226
..................... ANSI/AAMI/ISO 11137-3:2006 Sterilization
Relevant Guidance of Health Care Products--Radiation--Part 3: Guidance on Dosimetric Aspects
14-228
..................... ANSI/AAMI/ISO 11135-1:2007 Sterilization
Relevant Guidance of Health Care Products--Ethylene oxide--
Part 1: Requirements for Development,
Validation, and Routine Control of a
Sterilization Process for Medical Devices
14-261
..................... ANSI/AAMI/ISO 17665-1:2006 Sterilization
Relevant Guidance of Health Care Products--Moist Heat--Part 1: Requirements for the Development,
Validation, and Routine Control of a
Sterilization Process for Medical Devices
14-119
..................... ANSI/AAMI ST55:2003/(R)2008 Table-top
Reaffirmation
Steam Sterilizers
14-71
14-264
ANSI/AAMI ST8:2008 Hospital Steam
Withdrawn and replaced
Sterilizers
with newer version
14-249
14-265
USP 32:2009 Microbiological
Withdrawn and replaced
Examination of Nonsterile Products:
with newer version
Microbial Enumeration Tests
14-250
14-266
USP 32:2009 Sterility Tests
Withdrawn and replaced with newer version
14-251
14-267
USP 32:2009 Bacterial Endotoxins Test Withdrawn and replaced with newer version
14-252
14-268
USP 32:2009 Pyrogen Test (USP Rabbit Withdrawn and replaced
Test)
with newer version
14-253
14-269
USP 32:2009 Transfusion and Infusion Withdrawn and replaced
Assemblies and Similar Medical Devices
with newer version
14-254
14-270
USP 32:2009 Biological Indicator for Steam Withdrawn and replaced
Sterilization--Self Contained
with newer version
14-246
14-271
USP 32:2009 Biological Indicator for Dry- Withdrawn and replaced
Heat Sterilization, Paper Carrier
with newer version
14-247
14-272
USP 32:2009 Biological Indicator for
Withdrawn and replaced
Ethylene Oxide Sterilization, Paper
with newer version
Carrier
14-248
14-273
USP 32:2009 Biological Indicator for Steam Withdrawn and replaced
Sterilization, Paper Carrier
with newer version
14-238
..................... ANSI/AAMI/ISO 11140-5:2007 Sterilization
Contact person and of Health Care Products--Chemical
Relevant guidance
Indicators--Part 5: Class 2 Indicators for Bowie and Dick-type Air Removal Tests
14-171
14-274
ANSI/AAMI/ISO 15882:2008 Chemical
Withdrawn and replaced
Indicators--Guidance on the Selection,
with newer version
Use, and Interpretation of Results
14-49
14-275
ANSI/AAMI ST41:2008 Ethylene oxide
Withdrawn and replaced
Sterilization in Health Care Facilities: with newer version
Safety and Effectiveness
14-136
..................... ANSI/AAMI ST67:2003/(R) 2008 Sterilization Reaffirmation and of Health Care Products--Requirements for Relevant guidance
Products Labeled ``STERILE''
Page 46213
III. Listing of New Entries
In table 3 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 022.
Table 3.
Recognition No.
Title of Standard
Reference No. & Date
-
Biocompatibility
2-152
Biological Evaluation of Medical Devices--Part 10: Tests for ISO 10993 10:2002/
Irritation and Delayed-type Hypersensitivity Amendment 1
Amd.1:2006(E)
-
General
5-46
Sampling Procedures for Inspection by Attributes--Part 1:
ISO 2859-1:1999/Cor 1:2001
Sampling Schemes Indexed by Acceptance Quality Limit (AQL) for Lot-by-lot Inspection
5-50
Medical Devices--Application of Usability Engineering to
IEC 62366:2007
Medical Devices
-
In Vitro Diagnostics
7-204
Reference Method for Broth Dilution Antifungal
CLSI M27-A3
Susceptibility Testing of Yeasts
-
Materials
8-186
Standard Guide for Assessment of the Ultra High Molecular
ASTM F 2759--09
Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal
Devices
8-187
Implants for Surgery--Hydroxyapatite--Part 1: Ceramic
ISO 13779-1:2008(E)
Hydroxyapatite
8-188
Implants for Surgery--Hydroxyapatite--Part 2: Coatings of
ISO 13779-2:2008(E)
Hydroxyapatite
-
Neurology
17-8
Implants for Surgery--Active Implantable Medical Devices
ISO 14708-3 2008-11-15
Part 3: Implantable Neurostimulators (Neurology)
-
OB-GYN/Gastroenterology
9-59
Hemodialysis Systems
ANSI/AAMI RD5:2003/(R) 2008
-
Orthopedics
11-218
Implants for surgery--Wear of Total Knee-joint Prostheses-- ISO 14243-3:2004 Technical
Part 3: Loading and Displacement Parameters for Wear-
Corrigendum 1 testing Machines with Displacement Control and
Corresponding Environmental Conditions for Test
-
Sterility
14-276
Sterilization of Health Care Products--Moist Heat--Part 2:
ISO/TS 17665-2:2009
Guidance on the Application of ISO 17665-1
14-277
Microbiological Examination of Nonsterile Products: Tests
USP32:2009 for Specified Microorganisms
14-278
Biological Evaluation of Medical Devices--Part 7: Ethylene
ANSI/AAMI/ISO 10993-7:2008
Oxide Sterilization Residuals
I. Tissue Engineering
15-14
Standard Guide for Interpreting Images of Polymeric Tissue
ASTM F2603-06
Scaffolds
15-15
Standard Test Method for Determining the Chemical
ASTM F2259-03 (Reapproved
Composition and Sequence in Alginate by Proton Nuclear
2008)
Magnetic Resonance (1H NMR) Spectroscopy
IV. List of Recognized Standards
FDA maintains the agency's current list of FDA recognized consensus standards in a searchable database that may be accessed directly at
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications and minor revisions described in this document into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary.
Page 46214
V. Recommendation of Standards for Recognition by FDA
Any person may recommend consensus standards as candidates for recognition under the new provision of section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (See FOR FURTHER INFORMATION CONTACT). To be properly considered such recommendations should contain, at a minimum, the following information: (1) Title of the standard; (2) any reference number and date; (3) name and address of the national or international standards development organization; (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply; and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity.
VI. Electronic Access
You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the Federal
Register, this document announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 022'' will be available on the CDRH home page. You may access the CDRH home page at http:// www.fda.gov/cdrh.
You may access ``Guidance on the Recognition and Use of Consensus
Standards,'' and the searchable database for ``FDA Recognized Consensus
Standards'' through the hyperlink at http://www.fda.gov/cdrh/ stdsprog.html.
This Federal Register document on modifications in FDA's recognition of consensus standards is available at http://www.fda.gov/ cdrh/fedregin.html.
VII. Submission of Comments and Effective Date
Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) written or electronic comments regarding this document. Two copies of any mailed comments are to be submitted, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 022. These modifications to the list or recognized standards are effective upon publication of this document in the Federal Register.
Dated: August 26, 2009.
Catherine M. Cook,
Associate Director for Regulation and Policy.
FR Doc. E9-21609 Filed 9-4-09; 8:45 am
BILLING CODE 4160-01-S
